Vascular Access ComplicationTunDRANCT05311111
Efficacy and Safety of the Distal Radial Approach
A study testing distal radial artery approach and conventional radial artery approach in people with Vascular Access Complication and Coronary Artery Disease, run by General Administration of Military Health, Tunisia at 1 site in Tunisia.
Trial summary
The aim of this non-inferiority trial is to determine if the distal radial access (DRA) during percutaneous coronary intervention (PCI) has an acceptable efficacy compared to the reference access through the conventional radial artery (TRA) with a lower rate of radial artery occlusion (RAO) in real life practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Coronary Artery Disease
- What is being tested?
- distal radial artery approach and conventional radial artery approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Feb 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Hospitalized in the cardiology department of the military hospital of Tunis.
- elective Percutaneous coronary intervention performed by experienced operators or fellows trained in the proximal and distal radial approach
- Non-inclusion criteria:
- not provided written informed consent
- both radial arteries were used for prior catheterization
Show all 14Show fewer
- Under oral anticoagulation
- Having coronary bypass surgery
- Hemodynamic instability
- contra-indication to the radial approach:
- Orthopedic surgery: amputation
- Severe burns of both upper limbs.
- Radial artery pulse not palpable, negative modified Allen test or Barbeau classification type D
- Identified radial vascular anomaly: stenosis, fistula, tortuosity not allowing passage of the catheter
Who cannot join
- death within a short period of time after admission
- PCI by the same puncture site will be performed within 30 days after the first puncture
- lost to follow-up
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Military hospital of Tunis
Tunis, 1008
Stambouli Nejla, 0021655104234, nejlastam@gmail.com
Aymen Noamen, MD
About this study
Official title: Efficacy and Safety of the Distal Radial Approach in Percutaneous Coronary Interventions: Protocol of a Randomized Controlled Non-inferiority Trial
The aim of this non-inferiority trial is to determine if the distal radial access (DRA) during percutaneous coronary intervention (PCI) has an acceptable efficacy compared to the reference access through the conventional radial artery (TRA) with a lower rate of radial artery occlusion (RAO) in real life practice.
Read the detailed description
The conventional radial approach is the recommended vascular access for percutaneous coronary interventions. It is effective, feasible, but associated with a risk of occlusion of the radial artery.
The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery. However, few clinical trials in real life were conducted in North African patients.
This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach.
This trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional radial approach. Two hundred and fifty patients scheduled for percutaneous coronary intervention will be included. The two main endpoints are the puncture success rate with a non-inferiority margin of 10% and the rate of 30-day occlusion of the punctured radial artery.
Secondary endpoints: catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, QuickDASH score, pain score and operator satisfaction A single blind analysis will be led according to the per-protocol and intention-to-treat methods.
Avoiding occlusion of the puncture site allows to preserve the radial artery for subsequent coronary or cerebral percutaneous interventions as well as for coronary bypasses and hemodialysis fistulas. The results will provide the parameters related to the efficacy and safety of the distal radial approach, so improving clinical practice.
- Being tested
- distal radial artery approach, conventional radial artery approach
- Keywords
- Radial artery, coronary angiography, percutaneous coronary intervention, safety, efficacy, radial approach, anatomical snuff box
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal radial artery approachProcedure or surgery
Also called DRA
Procedure: Use of radial artery for access for a coronary angiography or intervention After preparation and local anesthesia, the operator will puncture the distal radial artery in the dorsum of the hand or the anatomical snuff-box. Then a sheath will be placed. A cocktail combining Risordan®, Loxen® and unfractionated heparin will be injected through the sheath. a wire will be introduced. At the end of the procedure, the sheath will be removed immediately and hemostasis by compression will be carried out with an elastic band for 12 hours. The choice of limb side, sheath, catheters will be chosen according to the operator's discretion.
conventional radial artery approachProcedure or surgery
Also called TRA
Procedure: conventional radial access for a percutaneous coronary intervention After preparation and local anesthesia, the operator will puncture the proximal radial artery at the conventional site in distal forearm. Then a sheath will be placed. A cocktail combining Risordan®, Loxen® and unfractionated heparin will be injected through the sheath. a wire will be introduced. At the end of the procedure, the sheath will be removed immediately and hemostasis by compression will be carried out with an elastic band for 12 hours. The choice of limb side, sheath, catheters will be chosen according to the operator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| distal radial artery approach | Experimental | Elective percutaneous coronary intervention by forearm radial artery through the distal radial artery in the dorsum of the hand or the anatomical snuff-box Receives: Procedure: distal radial artery approach |
| conventional radial artery approach | Active comparator | Elective percutaneous coronary intervention through conventional radial artery access Receives: Procedure: conventional radial artery approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture success rate
Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)
Measured: During the procedure
Radial artery occlusion rate
Use of ALLEN and Barbeau tests, if abnormal, color Doppler ultrasound to assess the patency of the radial artery will be realized.
Measured: 30 days
Secondary outcomes (7)
Crossover rate
Comparison of the access site crossover rate in each group to complete the staged procedure
Measured: During the procedure
Duration of the puncture
Exact measurement of puncture duration in seconds
Measured: During the procedure
Radial artery spasm
The incidence of vasospasm that necessitates additional medication or forces access site cross over is registered
Measured: During the procedure
Number of patients presenting hematoma
Hematoma according to Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) score, The score ranges from 1 (≤5 cm diameter) to 5 ( ischemic threat of the hand).
Measured: 24 hours
Pain scale
through 0-10 numeric pain rating scale, 0 being no pain and 10 being the worst pain imaginable
Measured: 24 hours
QuickDASH questionnaire
The Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH) score is used to assess hand function. The score ranges from 0 (no disability) to 100 (most severe disability)
Measured: 30 days
Operator satisfaction
through 0-10 rating scale; 0 being very dissatisfied; 0 being very satisfied
Measured: at the end of the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Feb 2022
- Primary completion30 May 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, single-blind, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Administration of Military Health, Tunisia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Aymen Noamen, MD, Principal investigator, military hospital of Tunis , Tunis EL manar University, Faculty of medicine of TunisNadhem Hajlaoui, Pr, Study director, military hospital of Tunis , Tunis EL manar University, Faculty of medicine of TunisWafa Fehri, Pr, Study chair, military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311111
- Sponsor's protocol ID
- santemilitaire7
- Acronym
- TunDRA
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben Amara A, Noamen A, Anouar Y, Chenik S, Hajlaoui N, Fehri W. Evaluation of the Distal Radial Approach in percutaneous coronary interventions. Controlled, randomized non-inferiority trial. Tunis Med. 2022 mars;100(3):192-202.
PubMed 36005910
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Distal Radial Approach in Percutaneous Coronary Interventions: Protocol of a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05311111
- Acronym / sponsor ID
- TunDRA / santemilitaire7
- Keywords
- Radial artery, coronary angiography, percutaneous coronary intervention, safety, efficacy, radial approach, anatomical snuff box
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- General Administration of Military Health, TunisiaResearch network
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this non-inferiority trial is to determine if the distal radial access (DRA) during percutaneous coronary intervention (PCI) has an acceptable efficacy compared to the reference access through the conventional radial artery (TRA) with a lower rate of radial artery occlusion (RAO) in real life practice.
Detailed description
The conventional radial approach is the recommended vascular access for percutaneous coronary interventions. It is effective, feasible, but associated with a risk of occlusion of the radial artery.
The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery. However, few clinical trials in real life were conducted in North African patients.
This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach.
This trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional radial approach. Two hundred and fifty patients scheduled for percutaneous coronary intervention will be included. The two main endpoints are the puncture success rate with a non-inferiority margin of 10% and the rate of 30-day occlusion of the punctured radial artery.
Secondary endpoints: catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, QuickDASH score, pain score and operator satisfaction A single blind analysis will be led according to the per-protocol and intention-to-treat methods.
Avoiding occlusion of the puncture site allows to preserve the radial artery for subsequent coronary or cerebral percutaneous interventions as well as for coronary bypasses and hemodialysis fistulas. The results will provide the parameters related to the efficacy and safety of the distal radial approach, so improving clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-center, single-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| distal radial artery approach | Experimental | Procedure: distal radial artery approachElective percutaneous coronary intervention by forearm radial artery through the distal radial artery in the dorsum of the hand or the anatomical snuff-box |
| conventional radial artery approach | Active comparator | Procedure: conventional radial artery approachElective percutaneous coronary intervention through conventional radial artery access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Over 18 years old.
- Hospitalized in the cardiology department of the military hospital of Tunis.
- elective Percutaneous coronary intervention performed by experienced operators or fellows trained in the proximal and distal radial approach
- not provided written informed consent
- both radial arteries were used for prior catheterization
Key exclusion criteria (3 listed)
- death within a short period of time after admission
- PCI by the same puncture site will be performed within 30 days after the first puncture
- lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distal radial artery approachAlso: DRAProcedure: Use of radial artery for access for a coronary angiography or intervention After preparation and local anesthesia, the operator will puncture the distal radial artery in the dorsum of the hand or the anatomical snuff-box. Then a sheath will be placed. A cocktail combining Risordan®, Loxen® and unfractionated heparin will be injected through the sheath. a wire will be introduced. At the end of the procedure, the sheath will be removed immediately and hemostasis by compression will be carried out with an elastic band for 12 hours. The choice of limb side, sheath, catheters will be chosen according to the operator's discretion. | Procedure or surgery | distal radial artery approach |
| conventional radial artery approachAlso: TRAProcedure: conventional radial access for a percutaneous coronary intervention After preparation and local anesthesia, the operator will puncture the proximal radial artery at the conventional site in distal forearm. Then a sheath will be placed. A cocktail combining Risordan®, Loxen® and unfractionated heparin will be injected through the sheath. a wire will be introduced. At the end of the procedure, the sheath will be removed immediately and hemostasis by compression will be carried out with an elastic band for 12 hours. The choice of limb side, sheath, catheters will be chosen according to the operator's discretion. | Procedure or surgery | conventional radial artery approach |
Primary outcome
Puncture success rate
Time frame: During the procedure
Comparison of Puncture success rate between two groups: Distal Radial Access (DRA) and conventional Trans Radial Access (TRA)
Radial artery occlusion rate
Time frame: 30 days
Use of ALLEN and Barbeau tests, if abnormal, color Doppler ultrasound to assess the patency of the radial artery will be realized.
7 secondary outcomes
Crossover rate
Time frame: During the procedure
Duration of the puncture
Time frame: During the procedure
Radial artery spasm
Time frame: During the procedure
Number of patients presenting hematoma
Time frame: 24 hours
Pain scale
Time frame: 24 hours
QuickDASH questionnaire
Time frame: 30 days
Operator satisfaction
Time frame: at the end of the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 36005910Ben Amara A, Noamen A, Anouar Y, Chenik S, Hajlaoui N, Fehri W. Evaluation of the Distal Radial Approach in percutaneous coronary interventions. Controlled, randomized non-inferiority trial. Tunis Med. 2022 mars;100(3):192-202.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aymen Noamen, MD principal investigator
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Nadhem Hajlaoui, Pr study director
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
Wafa Fehri, Pr study chair
military hospital of Tunis , Tunis EL manar University, Faculty of medicine of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distal radial artery approach and conventional radial artery approach in people with Vascular Access Complication and Coronary Artery Disease, run by General Administration of Military Health, Tunisia at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aymen Noamen, MD (0021620215773, no.aymen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puncture success rate (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05311111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.